CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 499 enrolled
Drug / intervention
Ciprodex® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02216071
NCT02216071Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa

Exela Pharma Sciences, LLC.·interventional·Posted Aug 13, 2014·Updated May 28, 2021

In Brief

A Phase 3 clinical trial evaluating Ciprodex® and EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension for Acute Otitis Externa. Completed, enrolled 499 participants across 48 sites in 2 countries.

Detailed Summary

The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Externa
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 13, 2014
Enrollment StartJul 20, 2014
Primary CompletionAug 11, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.9 years ago

Interventions

Ciprodex®drug

Treatment of acute otitis externa (AOE) when administered twice daily for 7 days

EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspensiondrug

Treatment of acute otitis externa (AOE) when administered twice daily for 7 days